FDA Approves First-in-Class Treatment for Non-Cystic Fibrosis Bronchiectasis

The US Food and Drug Administration (FDA) has approved Insmed Incorporated's (Nasdaq: INSM) first-in-class treatment, BRINSUPRI (brensocatib), for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. This approval marks a significant advancement in the management of NCFB, a chronic and progressive disease affecting hundreds of thousands of people in the US.

Key Takeaways:

• The FDA approval represents a paradigm shift in NCFB treatment, as BRINSUPRI is the first and only approved treatment to directly target neutrophilic inflammation and address a root cause of exacerbations.
• The treatment has shown a 21.1% and 19.4% reduction in annual rate of exacerbations in patients taking 10 mg and 25 mg of BRINSUPRI, respectively, compared to placebo.
• Patients taking BRINSUPRI 25 mg experienced statistically significant less decline in lung function, as measured by FEV1 after using a bronchodilator, at week 52.
• The most common adverse reactions in the ASPEN trial include upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension.
• The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions.
• Approximately 500,000 people in the US are diagnosed with NCFB, and it is estimated that millions more are living with this disease globally.
• Non-cystic fibrosis bronchiectasis deeply affects the lives of people living with this chronic lung condition, impacting both their physical health and emotional well-being.
• Insmed's approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine.

Statistics:

• Approximately 500,000 people in the US are diagnosed with NCFB.
• The approval of BRINSUPRI marks a significant advancement in the management of NCFB, a chronic and progressive disease.
• 21.1% reduction in annual rate of exacerbations in patients taking 10 mg of BRINSUPRI.
• 19.4% reduction in annual rate of exacerbations in patients taking 25 mg of BRINSUPRI.
• 56% of patients taking BRINSUPRI remained exacerbation-free over the treatment period.

Sources:

• Insmed Incorporated
• US Food and Drug Administration (FDA)
• New England Journal of Medicine
• ASPEN investigator, Doreen Addrizzo-Harris, M.D., FCCP
• Executive Director of the Bronchiectasis and NTM Association, Elisha Malanga